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    Clinical Trial Results:
    An open-label study of the safety and tolerability of repeated administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

    Summary
    EudraCT number
    		 2017-004060-35
    Trial protocol
    		 HU  
    Global end of trial date
    05 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2020
    First version publication date
    15 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IPP-201101/006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03427151
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Immupharma
    Sponsor organisation address
    5, rue du Rhône, Mulhouse, France, 68100
    Public contact
    Robert Zimmer , ImmuPharma, 00 618221650, robert.zimmer@immupharma.com
    Scientific contact
    Robert Zimmer , ImmuPharma, 00 618221650, robert.zimmer@immupharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with systemic lupus erythematosus (SLE) who had participated in the main study IP-005.
    Protection of trial subjects
    Pregnant and lactating womam was excluded. To prevent a risk of pregnancy, a test was done at each visit. Patients in age were asked to use adequate contraception to prevent the risk of pregnancy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Mauritius: 23
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 14
    Worldwide total number of subjects
    62
    EEA total number of subjects
    28
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    61
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Among other inclusion criteria, main inclusion criteria was that patients were eligible if they have previously participated into the phase III IP-005 study.

    Pre-assignment
    Screening details
    		 inclusion criteria were similar to phase III IP-005 study as the study IP-006 is a long term follow up study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    As it is an extension study from IP-005, it is an open label study

    Arms
    Arm title
    		 IPP-201101
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPP-201101
    Investigational medicinal product code
    Other name
    Lupuzor
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mcg in 1ml of reconstituted solution

    Number of subjects in period 1
    		IPP-201101
    Started
    62
    Completed
    55
    Not completed
    7
         Consent withdrawn by subject
    4
         Lack of efficacy
    2
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 62 62
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 61 61
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.50 ( 12.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 58 58
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    IPP-201101
    Reporting group description
    		 -

    Subject analysis set title
    safety analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The safety analysis set includes all patients who received one or more doses of IPP-201101 in the extension phase

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    It includes all patients who received one or more doses of IPP-201101 in the extension phase.

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    The primary objective of this study extension is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with systemic lupus erythematosus (SLE) who had participated in the main study IP-005
    End point type
    Primary
    End point timeframe
    7 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: It is a descriptive analysis
    End point values
    		 IPP-201101 safety analysis set
    Number of subjects analysed
    62
    62
    Units: adverse event
    55
    55
    No statistical analyses for this end point

    Secondary: the effect of IPP-201101 in the Clinical SLEDAI-2K total score

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    End point title
    		 the effect of IPP-201101 in the Clinical SLEDAI-2K total score
    End point description
    The Clinical SLEDAI has been evaluated at Visit 1 and final Visit. The Clinical SLEDAI is calculated with the SLEDAI 2K score irrespective of anti-dsDNA and complement (C3, C4). The loss of 4 points was considered as a response.
    End point type
    Secondary
    End point timeframe
    at week 28
    End point values
    		 IPP-201101 Full analysis set
    Number of subjects analysed
    62
    62
    Units: patients
        number (not applicable)
    22
    22
    No statistical analyses for this end point

    Secondary: remission of the disease

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    End point title
    		 remission of the disease
    End point description
    Remission of the disease is defined as a reduction of Clinical SLEDAI 2K score to 0.
    End point type
    Secondary
    End point timeframe
    at week 28
    End point values
    		 IPP-201101 Full analysis set
    Number of subjects analysed
    62
    62
    Units: patient
        number (not applicable)
    20
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    7 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Safety group
    Reporting group description
    		 -

    Serious adverse events
    		 Safety group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 62 (3.23%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    SLE flare
         subjects affected / exposed
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 62 (51.61%)
    Investigations
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    6 / 62 (9.68%)
         occurrences all number
    7
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    9 / 62 (14.52%)
         occurrences all number
    16
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 62 (8.06%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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